Advanced Quality Assurance Professional

6 days ago


bangalore, India beBeeQuality Full time

Job SummaryWe are seeking a skilled Quality Assurance Engineer to join our team and contribute to the development of cutting-edge artificial intelligence models for ECG-based diagnostics.ResponsibilitiesParticipate in cross-functional teams to support the software design and development lifecycle, ensuring compliance with regulatory requirements such as FDA 21 CFR 820.30 and EN/ISO 13485:2016.Develop and execute verification and validation test activities for Software as a Medical Device (SaMD) components, including Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Traceability Matrices, and Final Reports.Collaborate with project teams to ensure that development projects meet defined development process requirements.Facilitate risk management activities for projects in compliance with ISO 14971:2019.



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